JCVI

The Plastic Health Crisis

by Sinéad Murphy

On September 20th, the U.K. Government began its programme of Covid vaccination in schools, having approved the experimental mRNA injections for healthy children between the ages of 12 and 15.

Just over two weeks earlier, the Government’s advisory committee on vaccination and immunisation – the JCVI – announced that they could not, on health grounds, recommend these injections for 12 to 15 year-olds; the margins of benefit were simply too small, they said.

One week after that, the Government’s Chief Medical Advisor, Professor Chris Whitty, trumped the advice of the JCVI, recommending the Covid vaccinations for 12-15 year-olds after all. His word carried the day, and the programme that he sanctioned is now in train.

But on what grounds did Chris Whitty approve the Covid vaccines for children, given that the JCVI declined to approve them on health grounds? He approved them… on health grounds. Offering the vaccines to children of 12 to 15 years would assuage their fear of the virus and help them to feel that the Covid crisis is coming to an end, he claimed, and would therefore be a significant benefit for what he termed their “mental health”.

Such is the wily ascendancy of the concept of ‘health’ that having refused the vaccination of children on health grounds it then granted the vaccination of children on health grounds.

* * *

In his book Plastic Words, Uwe Pörksen described how certain concepts come to acquire infinite flexibility and dominance, enveloping our powers of describing and understanding in their apparently profound ubiquity.

Plastic words are not technical words, Pörksen advised, which are often strictly limited to contexts and therefore of more or less restricted relevance. Plastic words are ordinary words, which have been taken from common parlance, refracted through one or other field of science, and returned to everyday talk with a new, broadened application and a new, somewhat ambiguous, authority.

Examples of plastic words are: “development”, “progress” and “communication”. Banal terms plucked from their historical parameters of use and conferred with a quasi-technicality that is not the less effective for being vague and accommodating.

Unlike jargon words, we can and do use plastic words freely and easily, Pörksen argues. We say that “progress in strategies of communication supports social development”, or that “development of communication styles is linked to progress”. In so saying, we have said very little – these statements do not mean anything, really. But we have also said very much, tapping into a seam of apparently scientific understanding that is sophisticated and worthy of being considered. We have given our talk a modern aura, and availed ourselves simultaneously of the unobjectionableness of common sense and the force of expertise.

Plastic words denote nothing, as Pörksen expresses it – the statement “progress in communication aids development” is nonsense. But plastic words are richly connotative. So much so that they suck the life from more specific, more nuanced, vernacular words, which are overshadowed by the apparent sophistication of plastic words and gradually fall out of favour.

There is an underbelly to using plastic words, however. The air of modern sophistication with which they infuse our descriptions is a thin one. Having revelled in its effect, we are bereft of any real appreciation of the stakes in whatever it is we have used them to describe, and must rely on professional analysis and advice for any substantial judgment. Using plastic words remakes us into clients of experts, Pörksen observes.

For this reason, the more we have recourse to plastic words, the less we are able to accurately describe and understand ourselves, each other and the world around us. Until at last we are at the mercy of expert analysis and advice, even for understanding events and negotiating situations that are quite concrete and personal.

* * *

In this context, it is worth considering what it might be like to use language that is not overshadowed by plastic words.

For this, two letters written by Jane Austen will do very well. They were sent to her sister Cassandra in the penultimate week of the year 1798, when the author was twenty-three and her sister two years older and the latter was staying with their brother Edward for the holiday season.

The first of these letters includes the following:

My Mother continues hearty, her appetite and nights are very good, but her Bowels are still not entirely settled, and she sometimes complains of an Asthma, a Dropsy, Water in her Chest and a Liver Disorder. The third Miss Irish Lefroy is going to be married to a Mr. Courtenay, but whether James or Charles I do not know… (December 1978.)

The second letter includes this:

Poor Edward! It is very hard that he who has everything else in the World that he can wish for, should not have good health too. – But I hope with the assistance of Bowel complaints, Faintnesses and Sicknesses, he will soon be restored to that Blessing likewise. – If his nervous complaint proceeded from a suppression of something that ought to be thrown out, which does not seem unlikely, the first of those Disorders may really be a remedy, and I sincerely wish it may, for I know no one more deserving of happiness without alloy than Edward is. – My Mother’s spirits are not affected by her complication of disorders; on the contrary they are altogether as good as ever; nor are you to suppose that these maladies are often thought of. – She has at times a tendency towards another which always relieves her, and that is, a gouty swelling and sensation about the ancles. – I cannot determine what to do about my new Gown; I wish such things were to be bought ready made…

One striking aspect of these short excerpts is the degree of involvement that they reveal, of two young women in the health concerns of their family members. Jane and her sister might well be expected to be too vibrant themselves to have much care for the low-level aliments of their parent and sibling. But not only are they exercised by these ailments, they trade in the most intimate and specific details about them: even their relations’ bowel movements are discussed, quite unhesitatingly and with interest.

Yet, this is no obsessiveness with matters of health. Jane trips lightly from the water in her mother’s chest to the romantic fortunes of a young neighbour and from the swelling in her mother’s ankles to the question of a new gown. Evidently, details of the condition of bodies and minds are common fare in the sisters’ conversations, woven seamlessly with other strands of daily interest.

Most striking of all in these excerpts, however, is the range of words that they have recourse to: “Dropsy,” “a gouty swelling and sensation”, “Liver Disorder”, “Water in the Chest”, “Faintnesses”, “settled Bowels”, “nervous complaint”, “something that ought to be thrown out”.  The sisters are well versed in the lexicon of maladies and remedies, their talk of such matters honed through constant practice.

The word “health” does make an appearance in these excepts – Edward’s “good health” is hoped for. But the word does not dominate, it does not have a special status, it does not overshadow the lively evocativeness of something being “thrown out” or of the “gouty swelling”. For it has yet to be transformed into a plastic word which grants its user the air of being very well-informed and up-to-date but also robs him of Austen-like powers of description and intervention, implicitly rendering him as subject to health institutions and their professionals.

The Invisible Committee, in their book The Coming Insurrection, wrote of the tendency of modern societies to stifle whatever it is that circulates between ourselves so that we are made helpless in negotiating the most basic components of our lives and must rely upon the expertise that is offered to us by institutions – of education, law, care, health, and so on.

A large part of this effect is produced by the roll-out of plastic words, which redirect even the most common pathways for the circulation of all that matters to us in our lives so that they pass through the official channels.

Jane Austen died at the age of 42. While there is dispute as to the cause of her death, it is most commonly attributed to Addison’s Disease. In our time, those who suffer from this disease are expected to enjoy a normal life span. Few would deny that this represents real medical progress, and that institutional expertise often produces admirable results.

However, the pursuit of medical progress and the circulation of health matters between ourselves are not mutually exclusive. Indeed, they ought to be complimentary. The problem, then, is not that experts and the institutions that support them exist and are at work, but that the kind of care for health that can only be undertaken as a low hum of daily describing and reporting and diagnosing and treating has been smothered by the seeming sophistication of plastic-word describing and reporting and diagnosing and treating, and we are reduced to relying on experts when we ought to take care of ourselves.

Perhaps no aspect of our lives has suffered from this smothering of our ability to look after ourselves as what is now summarised as ‘mental health’. Old people’s tears of loneliness – including on account of their Covid self-isolation; young people’s slump of disaffection –  including on account of their Covid estrangement from friends; parents’ palpitations of anxiety – including on account of their Covid confinement to home; students’ demotivation – including on account of the Covid cancellation of exams: all, and so much more, described as problems of ‘mental health’ and thereby at once robbed of their real significance and submitted to blanket solutions determined upon by professionals.

Care for our own and one another’s bodies and minds should circulate between us as easily as it circulated between Jane and Cassandra Austen, as easily as gossip about love and musings about gowns. But its circulation has largely been suspended by the creep to ubiquity of the concept of ‘health’, which has destroyed our confidence to look after ourselves and one another. So much so that when it comes to caring for our own children, we are deprived of proper faith in their native vigour and immunity and submit them to an ongoing medical trial whose medium- and long-term effects are unknown and whose short-term effects are already established as worrying.

Lost for words to describe and therefore understand the welfare of our children, we appeal to Chris Whitty to know what is best for them.

* * *

The most sinister moment in Pörksen’s account of the rise of plastic words is his claim that they displace, not only more nuanced, vernacular words, but also the silence that used to surround them. There is nowhere, Pörksen argues, that ‘progress’ is not important, no corner in which ‘development’ is not desirable, no instant when ‘communication’ does not occur.

Our concept of ‘health’ is fulfilling Pörksen’s grim prediction, inserting itself as a stake in the most out-of-the-way corners of our lives. We speak of “emotional health”, of “financial health”, of “relationship health”, of “personal health”, of “social health”, of “healthy eating”, a “healthy planet” and “healthy lifestyles”. There is no nook in which ‘health’ is not a possibility, no cranny in which expert advice must not be sought.

Jane Austen could leave her talk of health matters as easily as she could take them. She could dither blithely about her new gown and report breezily on her neighbour’s romance. But in our Covid era, there is no domain in which health is not at stake. Even gowns, even romance, fall under its sober shadow, as we browse in shops with sanitized hands and masked faces, and flick past the vaccination status of love prospects on Tinder.

Now, there is talk of ‘health’ everywhere and everywhere is a ‘health centre’: surgical masks handed out at the doors of churches; sanitized hands waved to the music at rock concerts; and experimental medicines administered in the classrooms of schools.

Dr. Sinead Murphy is an Associate Researcher in Philosophy at Newcastle University.

Advice for Parents Concerned About the Vaccination of Their Healthy Children

The Covid vaccine roll-out for healthy 12-15 year-olds is due to begin this week, but scientists remain concerned about the likely side effects. Some teachers tell me their schools still aren’t fully aware of the role they are supposed to play – “I can see it becoming a minefield”, said one teacher at a school in Yorkshire – and there seems to be some confusion among parents about the power they hold. Can they withhold their consent for the vaccination of their children or not?

Parents will be sent consent forms but only, it seems, as a formality since children who are deemed ‘competent’ (the assessment of which contains no set of defined questions) will be able to overrule the decisions of their parents anyway. This is of a piece with the Government’s decision to push ahead with its roll-out despite being told by the Joint Committee on Vaccination and Immunisation (JCVI) that “there is considerable uncertainty regarding the magnitude of the potential harms” of Covid vaccination in healthy teenagers and that – given the small risk Covid poses to healthy 12-15 year-olds – the “margin of benefit… is considered too small”.

The JCVI is “generous” in its assessment, according to an executive at a pharmaceutical company writing for the Daily Sceptic. (He, by the way, believes vaccines are among the “three greatest medical innovations”, so could hardly be labelled “anti-vax”!) Responding to the data, he says there is a “serious enough” risk of children developing myocarditis after vaccination (inflammation of the heart muscle, the long-term consequences of which aren’t fully understood) whereas the benefits of vaccination are “not well quantified” by the JCVI. The body also fails to properly consider the risk of other conditions following vaccination.

Professor Adam Finn sums up the situation by saying the vaccination of children would not – in normal times – have been approved because of the possible risks. He believes that parents are justified in waiting to allow their children to get ‘jabbed’ until these risks are better understood. But therein lies the problem. What – if anything – can parents do to delay the vaccination of their children?

Covid Vaccines for Children Would Not Be Approved before Full Investigation in Normal Times, Says Government Advisor

These – undoubtedly – aren’t normal times. If they were, the Covid vaccine would not have been approved for healthy children until it had been fully investigated, says Professor Adam Finn. He adds that parents are justified in waiting until more is understood about the risks of vaccinating children before getting their teenagers ‘jabbed’. The Times has the story.

Professor Finn, a member of the Joint Committee on Vaccination and Immunisation, says that in normal times, the vaccine would not have been recommended for widespread use in children until the long-term consequences of rare side effects had been fully investigated.

Parents are justified in waiting until the risks are clearer before getting their teenagers vaccinated and the NHS needs to spell out the uncertainty over long-term effects better, he argues on this page.

He fears that if some children eventually suffer lifelong health risks without being told of known concerns, trust in other vaccination programmes and wider Government health advice will be undermined. …

Given the huge uncertainty over the extent of the risks, Finn, professor of paediatrics at the University of Bristol, is concerned that parents and children have not fully understood the concerns that gave the JCVI pause and led to months of agonising over whether children should be offered the jab.

Finn insists that doctors need to be transparent about the “extremely uncommon” risks. He says that expert disagreement over possible side effects “cannot be an argument to downplay important information or to present the evidence as clearly pointing only in one direction when it doesn’t”.

An NHS leaflet to be given to children says only that “most people [suffering heart inflammation] recovered and felt better following rest and simple treatments”.

Writing with Guido Pieles, the consultant cardiologist who advised the JCVI, Finn explains that U.S. cardiologists are seeing signs of scarring in the hearts of otherwise healthy teenagers who suffer rare post-vaccine inflammation.

While they say that it is “perfectly possible that these changes will resolve completely over time”, they warn that such scarring is known to carry a risk of “life-threatening arrhythmias or sudden cardiac arrest”.

As coronavirus vaccines are so new, it is not yet known if the same serious long-term dangers will result. However Finn and Pieles said that “in normal times a rare, new and poorly understood process of this kind would be painstakingly studied over a longer period before any decisions were made”.

Given the pandemic, they acknowledge that many believe “we currently don’t have the luxury of time for more evidence”, making it much harder to issue authoritative advice.

Finn and Pieles suggest that parents consider waiting six months or so until the longer-term consequences of heart changes start to become clear, saying: “This is not a decision that needs to be rushed, and choosing to wait for more evidence is perfectly legitimate.”

Worth reading in full.

The Ethical Bankruptcy of Vaccinating 12-15 Year-Olds

We’re publishing an original piece today by a senior pharmaceutical company executive setting out the ethical case against vaccinating healthy 12-15 year-olds against SARS-CoV-2. He points out that the risk of myocarditis alone is greater than any potential benefit of being vaccinated for this cohort. There are 3,200,000 12-15 year-olds in the U.K. and if you give a single dose of the vaccine to every one, according to the JCVI, you’re likely to prevent seven children ending up in the paediatric ICU. That’s not seven per million; that’s seven in total. But, according to the same source, the risk of a 12-15 year-old who’s received one dose developing myocarditis is 3-17 per million, so if every child in this cohort receives one dose between 9-54 will develop vaccine-induced myocarditis. Since we don’t know the long-term impact of myocarditis on a person’s health, this data suggests the risk of vaccinating 12-15 year-olds outweighs the risk – and that’s to ignore all the other potential side effects of the Covid vaccines.

Here are two key paragraphs, although the whole piece is excellent:

When it comes to the vaccine-induced safety risks, such as myocarditis, we do not have enough data to adequately assess what they mean for this vulnerable group and, as a result, we do not know how to satisfactorily manage them. This was the point the JCVI was making when raising concerns about the long-term risks. I must also emphasise again; children are not small adults and for 12-15 year-olds with hormones racing and puberty in full swing we cannot necessarily transfer any knowledge or assessment of risks from the adult population to this group. It may be that the risks are short-term, manageable, and acceptable and so the balance of benefit/risk is okay… but the fact is we simply do not know, and finding out by immunising 100,000s of children in uncontrolled circumstances is no way to discover the truth. One cannot ignore these risks just because “they are very rare”, especially when the significant benefits may also be “very rare”.

This is a clear case of where the precautionary principle should be applied and where we should assume the worse outcomes and manage the situation accordingly. Here, we’d assume there will be long-term issues associated with vaccine-induced myocarditis, put in place a routine monitoring plan for those who have already suffered this adverse event to ensure they remain healthy and detect any issues as soon as we can, and not vaccinate anyone else in this group until we understand what, if any, long-term issues there may be. It is ironic to me that the precautionary principle has been wielded by the Government and their advisors to justify a whole host of unproven interventions during the COVID-19 pandemic (think masks, think lockdown), but it appears that when it gets in the way of a desired policy implementation it is something that can just be forgotten. As Groucho Marx once said: “Those are my principles, and if you don’t like them… well, I have others.”

Worth reading in full.

Stop Press: Professor David Paton has come at the same issue from a different angle and reached the same conclusion. He’s examined the argument that vaccinating healthy 12-15 year-olds will reduce the disruption to children’s education in the Spectator and concluded that it’s nonsense. He originally set out this critique in a Twitter thread and that prompted Julia Hartley-Brewer to have him on her show to flesh out the argument. You can see a clip here.

The Ethical Bankruptcy of Vaccinating 12-15 Year-Olds Against SARS-CoV-2

by George Santayana

The Declaration of Geneva of the World Medical Association binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.

From the General Principles in the Declaration of Helsinki.

Let me start with a couple of confessions.

My first confession is that I work in the pharmaceutical industry and have done so for far more years than I’d like to admit (a Big Pharma Shill as one BTL commentator so kindly put it!). My second confession is that I’m a big fan of vaccination. I believe that clean water, vaccinations, and antibiotics are the three greatest medical innovations and together have probably saved more lives than all other medicines put together. But that said, I’m a supporter of vaccinations in the same way that I’m a proponent of any medical treatment… when it is the right treatment for the right person at the right time.

So, with those confessions off my chest, you can see that when I say that I believe that the proposed vaccination of healthy 12-15 year-olds against COVID-19 is morally, clinically and ethically wrong I am doing so from the perspective of a boringly mainstream industrial scientist and someone firmly on the inside of the large pharma Evil Empire.

Like many things in life, medical treatments come with some level of risk to the person receiving them and these risks need to be balanced against the benefit to this person. The balance of benefit and risk for a treatment can be a very individual affair and it is one of the skills of the doctor to make this judgement for their patient. In my world, understanding the balance of benefit/risk for new medicines is one of the main aims of drug development and the aim of good quality clinical trials is to try and fairly demonstrate that the benefits of a new treatment outweigh the risks to the patients who will be receiving it.

Benefit/risk can be quite nuanced, but in the case of vaccinating 12-15 year-olds against SARS-CoV-2, it is very clear. You can read the JCVI’s statement on COVID-19 yourself and form your own judgement based on the figures which are presented in the report, which I have reproduced below.

Tables One-Four taken from the JCVI statement on COVID-19 vaccination of children aged 12 to 15 years: September 3rd, 2021.

First, the benefits. There are approximately 3,200,000 12-15 year-olds in the U.K. and so we can convert the figures from the tables which are presented as X/million in the JCVI report into a number of cases based on this population. From Table One, one vaccination dose is predicted to prevent seven children ending up in the paediatric ICU, 278 hospitalisations and 49 cases of paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 infection (PIMS-TS). You can straight away see from Table Two that there is almost no additional benefit to a second dose which means that after two doses (Table Three), we only prevent eight kids ending up in the paediatric ICU, 296 hospitalisations and 88 cases of PIMS-TS.

It is unclear if these benefits are accumulative or over-lapping, i.e., are the ICU patients in addition to non-ICU hospitalisations and are the PIMS-TS patients counted separately or do some end up in hospital? I suspect there is some double-counting here. Also, the long-term outcomes of the hospitalisations and PIMS-TS cases are not discussed and so we don’t really know how many of the prevented outcomes would result in long-term problems for the children involved if they weren’t prevented. Clearly, the ICU cases are serious, but what about the other hospitalisations? Do these range from day-cases to long-term, more serious stays? The “T” in PIMS-TS is “temporally” so does this suggest that this syndrome resolves and, as unpleasant as it might be, is not life-threatening? Also, the word “syndrome” means that it encompasses a huge range of symptoms and so, one assumes, comes in a range of severities. Overall, these benefits are not well quantified in this summary document but taken at face value it does appear that there is some rationale to vaccinating 12-15 year-old children to avoid serious COVID-19 related illness.

But that’s just one side of the equation. What about the risks? Or more specifically, what about the risk, because the JCVI seems to have only really focused on the risk of myocarditis… but to be honest, they don’t really need to go much beyond this.

The risk of developing vaccine-induced myocarditis (inflammation of the heart muscle) (Table Four) ranges from approximately one in 330,000 to one in 60,000 following one dose rising to one in 83,000 to one in 30,000 after two doses. So, again assuming there are about 3.2 million 12-15 year-olds in the U.K. and we vaccinated all of them, we could expect between 9-54 cases of vaccine-induced myocarditis following one dose and between 38-108 cases if we double vaccinated. Serious enough in itself but compound by the fact, as highlighted by the JCVI, that we don’t know what, if any, the long-term consequences are for the children who develop myocarditis after vaccination.

No wonder the JCVI wasn’t supportive. To say that the benefit/risk is marginally positive is to be generous. Even for one vaccine dose the lower estimates of vaccine-induced myocarditis exceed the predicted reduction in the number of severe hospitalisations (CPU cases) and generating potentially long-term cardiac issues in healthy children to avoid a small number of serious COVID-19 cases in this cohort seems to go against the principle of “first do no harm”. For two doses it’s much worse because we gain almost no additional benefit but more than double the risk of adverse cardiac events. And this is only considering this one adverse event and ignoring all the other potentially serious safety problems.

Under normal circumstances, there is no way this would be approved as a treatment for this group. Yet here we are with the U.K. Government about to embark on the vaccination of 12-15 year-olds.

Something that is often glossed over as some kind of “detail” by those strongly advocating immunising as many people as possible against SARS-CoV-2 is that these are not approved medicines but are being used under emergency legislation. This means they are experimental treatments, not because they have never been trialled but because they haven’t completed the normal suite of clinical studies that are required for a vaccine to be authorised for use as a medicine in normal clinical practice. For their use in children, we also need to remember that youngsters are not just small adults but have their own unique physiology and so we can’t assume that adult results are relevant. Paediatric drug development is not a simple case of scaling down the adult dose but requires a whole host of dedicated studies and specific assessments. Which means that for the paediatric use of these vaccines the prior clinical data on their safety and efficacy is extremely limited despite millions of adults receiving the vaccine.

The bottom line is that, until approved, these vaccinations will remain experimental treatments, and far from this being a “detail” it means that ethically and clinically we should treat them as medicines in development and not as established drugs.

Experimental treatments are developed within the framework of good clinical practice or GCP. Within the U.K. and Europe, GCP is described in the nattily titled document “ICH E6 (R2) Good Clinical Practice”.  This document defines the roles and responsibilities needed to develop a new medicine and is not just a guide to best practice but sets out some of the legal frameworks that anyone developing drugs here must adhere to. I’m not intending to describe ICH E6 (R2) in any detail but have provided a link for those interested in learning more about what goes into a clinical trial… or perhaps suffering from insomnia. What I want to highlight is that GCP is underpinned by some core ethical principles, explicitly those described in the Declaration of Helsinki which itself is founded upon the principles in the Nuremberg Code.

So, when we consider the use of the current COVID-19 vaccinations, it is the principles of GCP that I believe should be guiding us. Principles that the vaccination of children against SARS-CoV-2 ignore.

The Nuremberg Code was developed by the war crimes tribunal after the Second World War and put down 10 standards to which physicians must conform when experimenting on human subjects. It is this code that articulates the core requirement of voluntary informed consent. Informed consent isn’t some nice-to-have, but a fundamental human right that enshrines the rights of an individual to control what happens to their own body. It is also a right that has been undermined through the use of rewards and coercion in order to achieve a perceived societal benefit from COVID-19 vaccination. In fact, as I have discussed in a previous article, the destruction of informed consent is the logical consequence of assuming that society has some rights to decide which medical procedures are in the best interest of the population and once we do decide that this is ok, we start down a rocky road to a very unpleasant destination.

The Declaration of Helsinki was adopted by the World Medical Association in 1964 and builds on the Nuremberg Code to develop a set of ethical principles for medical research involving human subjects. I’ve started this article with the first of the General Principles in the Declaration which essentially asserts that it is the heath and best interests of the patient that must be the paramount consideration for a physician. Just like the Nuremberg Code, the Declaration of Helsinki focuses on the individual patient’s rights and how, regardless of the broader aims and benefits of the medical research, it is unethical to do this research if the individual’s rights are broken. And, like the Nuremberg Code, the rights described in the Declaration of Helsinki are just as open to erosion and destruction as soon as we start to consider potential societal needs over and above those of the individual.

In the Declaration of Helsinki, there is a section dealing with “Vulnerable Groups and Individuals” into which 12-15 year-old children would clearly fall. This states:

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

It is explicit from this principle that the vulnerable group must be the main beneficiaries of the treatment and so any justification of vaccinating children to help protect others outside of this group destroys this principle and so is unethical. As described above, in the JCVI’s assessment there are some potential benefits associated with COVID-19 vaccination to 12-15 year-olds, but are they a health need or a priority? The loss of a young life is a tragedy and so avoiding this loss, if possible, would seem sensible but we cannot forget the risks of the treatment in our drive to achieve this benefit. A point that the Declaration of Helsinki makes clear in its section on “Risks, Burdens and Benefits”:

Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. (My emphasis.)

And this is the key reason why vaccinating healthy 12-15 year-olds is so emphatically wrong.

When it comes to the vaccine-induced safety risks, such as myocarditis, we do not have enough data to adequately assess what they mean for this vulnerable group and, as a result, we do not know how to satisfactorily manage them. This was the point the JCVI was making when raising concerns about the long-term risks. I must also emphasise again; children are not small adults and for 12-15 year-olds with hormones racing and puberty in full swing we cannot necessarily transfer any knowledge or assessment of risks from the adult population to this group. It may be that the risks are short-term, manageable, and acceptable and so the balance of benefit/risk is okay… but the fact is we simply do not know, and finding out by immunising 100,000s of children in uncontrolled circumstances is no way to discover the truth. One cannot ignore these risks just because “they are very rare”, especially when the significant benefits may also be “very rare”.

This is a clear case of where the precautionary principle should be applied and where we should assume the worse outcomes and manage the situation accordingly. Here, we’d assume there will be long-term issues associated with vaccine-induced myocarditis, put in place a routine monitoring plan for those who have already suffered this adverse event to ensure they remain healthy and detect any issues as soon as we can, and not vaccinate anyone else in this group until we understand what, if any, long-term issues there may be. It is ironic to me that the precautionary principle has been wielded by the Government and their advisors to justify a whole host of unproven interventions during the COVID-19 pandemic (think masks, think lockdown), but it appears that when it gets in the way of a desired policy implementation it is something that can just be forgotten. As Groucho Marx once said: “Those are my principles, and if you don’t like them… well, I have others.”

I can perhaps understand politicians not being au fait with the details of ICH E6 (R2), but they should be aware that with experimental treatments like the COVID-19 vaccinations, they are in effect the sponsors of a massive real-world clinical trial:

[The sponsor is] An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial.

(ICH E6 (R2), Section 1.54)

As sponsors, the Government and politicians are ultimately responsible and accountable for what happens to people taking this experimental treatment. Even trying to make 12-15 year-old children somehow legally competent to make the decision about being vaccinated does not abrogate them of their responsibilities. So I’d suggest that they familiarise themselves with the principles in the Declaration of Helsinki and the Nuremberg Code and read about GCP, because you never know but perhaps at some future point a competent authority could come knocking on the door.

The ignorance of politicians is one thing, but ignorance of these frameworks and their ethical principles cannot be an excuse used by senior clinicians who are recommending using partially tested treatment on youngsters. Inventing additional benefits not directly related to treatment, such as positive impacts on mental health, to try and justify the use of these vaccinations might help them sleep at night but doesn’t change anything. They are still, in my opinion, breaking ethical and professional principles… principles which they swore to uphold. Unfortunately, it wouldn’t be the first time that doctors have given a political decision a veneer of medical respectability. History will be the judge.

What can we do? Probably not a lot. If the Government and their senior advisors are going to ignore the clear recommendations of their own experts, then individuals outside of these circles have no chance. Perhaps, send your MP a copy of the JCVI’s assessment and point out that the precautionary principle means that vaccinating children where there is a clear, poorly understood safety finding is unethical and immoral, irrespective of how rare the finding might be. Send them the Declaration of Helsinki and point out that they are ultimately responsible for what happens in these vaccination campaigns and to reflect on which side of the ethical argument they want to be on. Probably a futile endeavour, but at least they might understand that they are no longer “following the science” and hiding behind the recommendations of a group of politically connected senior doctors and academics is not going to wash their hands of any issues that arise with this policy. Ultimately though, COVID-19 vaccination of our children will now go ahead and although some parents and children will refuse the jab, I suspect many more won’t and so the only thing really left to do is to pray that the Government and their advisors turn out to be right… right that vaccinating 12-15 year-olds is actually in their best interests and that any vaccine-induced adverse events are rare, transient and do not have any long-term consequences. The alternative is one I shudder to contemplate.

George Santayana is a pseudonym. The author is an executive at a pharmaceutical company.

Tory MP Calls on Chris Whitty to Resign after Giving Green Light for Vaccination of All Healthy Teenagers

Chief Medical Officer Chris Whitty should resign for approving the vaccination of all healthy teenagers against Covid “without good clinical reason”, according to Marcus Fysh MP. The Independent has the story.

A row broke out on Monday after the government announced 12 to 15 year-olds will be offered one Pfizer jab from next week, following a decision made by the chief medical officers (CMO) of each of the U.K.’s four nations…

Responding to the move in a tweet on Monday night Marcus Fysh, the Conservative MP for Yeovil, claimed Prof Whitty “does not deserve the confidence of the country” as he called for him to step down.

Speaking in the House of Commons earlier, Mr. Fysh said he had “grave concerns about this policy and the fact that the CMOs have made their decision on the basis of the educational impact rather than the health of the children at clinical level”.

In a previous ruling the JCVI, which looks at vaccinations from a purely clinical perspective, concluded that the virus presents a very low risk for children and therefore an inoculation programme would offer only minor benefits.

The CMOs, who had come under significant political and media pressure to approve the roll-out, told a Downing Street press conference on Monday that there were other benefits, including reducing the disruption to the school term.

Professor Whitty told the news conference it had been a “difficult decision” but CMOs would not be recommending the jabs “unless we felt that benefit exceeded risk”.

Three million eligible teenagers will be offered a first dose as early as next week as part of in-school vaccination services.

Worth reading in full.

Stop Press: Appearing on talkRADIO later on Tuesday, Marcus said the vaccination of healthy children is “an appalling decision [that’s] not based on medical need or clinical need”.

They’ve come up with the idea, because the JCVI didn’t think it was warranted, that somehow children’s mental health is a clinical need for this vaccination. Well, I’m sorry [but] we need to lead children to a better place of understanding they are not at risk if they are worried about getting Covid. It just is not something that is going to be dangerous for them. I just don’t buy that for a second and I think it’s an outrageous way that the medical advice has been manipulated.

Chief Medical Officers Say All U.K. Teenagers Should Be Vaccinated against Covid

The U.K.’s four Chief Medical Officers have advised that all healthy teenagers should be vaccinated against Covid, while admitting that “in those aged 12-15, [the virus] rarely, but occasionally, leads to serious illness, hospitalisation and even less commonly death”. The decision will trigger the launching by the Government of a vaccine roll-out for 12-15 year-olds, despite ministers being warned by the JCVI of the risk of side effects. The Telegraph has the story.

Professor Chris Whitty and his counterparts in Wales, Scotland and Northern Ireland said the benefits of vaccinating young people and reducing transmission of the virus outweighed potential costs of side effects for children and disruption to school timetables.

They also recommended that ministers “present the risk-benefit decisions in a way that is accessible to children and young people, as well as their parents”. 

“A child-centred approach to communication and deployment of the vaccine should be the primary objective,” they said.

Boris Johnson, Professor Chris Whitty and Sir Patrick Vallance, the Chief Scientific Adviser, will give a press conference on Tuesday in which the Prime Minister is expected to announce he has accepted his chief medical officers’ advice and the rollout for 12 to 15 year-olds will begin.

A similar roll-out for children aged 16 and over is already running.

In a letter to Sajid Javid, the Health Secretary, and other health ministers in devolved parts of the U.K., the medical officers warned that “in those aged 12-15, Covid rarely, but occasionally, leads to serious illness, hospitalisation and even less commonly death”.

“The risks of vaccination (mainly myocarditis) are also very rare,” they said. …

They… warned that individual choice to receive the vaccine or not should be respected.

“It is essential that children and young people aged 12-15 and their parents are supported in their decisions, whatever decisions they take, and are not stigmatised either for accepting, or not accepting, the vaccination offer,” they said, adding that information on the jabs should be communicated in a “child-centred” way.

Worth reading in full.

Backbench Rebellion Brewing Over Plans to Vaccinate Kids

Ministers faced a backbench rebellion on Friday night over plans to vaccinate healthy 12-15 year-olds after 26 Tory MPs warned the Government that overruling expert advice risks “dissolving the bond of trust” between the public and the Government. The Telegraph has more.

In a letter to Sajid Javid, the Health Secretary, MPs said that the Government’s willingness to “ignore” the Joint Committee on Vaccination and Immunisation (JCVI) is a cause for “serious concern”.

Their intervention comes as Prof Chris Whitty, England’s Chief Medical Officer, prepares to advise ministers on whether there is a wider benefit to society from vaccinating children.

In the letter, MPs pointed out that a “large part” of the UK’s inoculation programme success stems from the work of the JCVI which had “successfully determined the priorities for the vaccination rollout since January”.

They added: “As a result of their leadership, the UK has one of the lowest levels of vaccine hesitancy in the world, and so far over 90 per cent of the adult population has felt enough trust in its analysis to confidently have at least one vaccine dose.

“Every step of the way, from the first jab administered back in December, to three quarters of us now being fully vaccinated, the JCVI has brought the country along with it.”

Signatories of the letter include Esther McVey, the former secretary of state, Sir Graham Brady, the chairman of the 1922 committee of backbench MPs, and William Wragg, the chairman of the public administration and constitutional affairs committee.

MPs said they are concerned that any attempt by the Government to “overrule” the advice now risks “dissolving the bond of trust that has grown between state and public”.

Last week, the JCVI delivered its long-awaited verdict, saying the “margin of benefit” of jabbing 12-15 year-olds was “considered too small” and citing the low risk to healthy children from the virus.

Worth reading in full.

Children Should Be Vaccinated to Benefit Their Mental Health, Chris Whitty to Say

After months and months of recommending lockdown policies that damaged the mental health, education and social development of young people, Chris Whitty is now set to recommend that children aged 12 and over should be vaccinated against Covid “to benefit their mental health, education and social development”, according to the Times.

The Chief Medical Officer for England is set to conclude a review of medical evidence early next week, with ministers promising that the first younger teenagers will be jabbed within five working days. …

Whitty and his counterparts in Scotland, Wales and Northern Ireland are finalising a review into the wider benefits of child vaccination after the Joint Committee on Vaccination and Immunisation gave them responsibility for making a decision. [Or, rather, after the Government chose to ignore the JCVI.]

The committee concluded last week that although the benefits of vaccinating healthy children aged 12 to 15 slightly outweighed the risk, the balance in favour was too small to justify mass immunisation on health grounds alone. They said Whitty should be tasked with considering the broader benefits to children and his review has been holding discussions this week.

The Times understands that talks with senior doctors and other experts reached the conclusion that vaccination should go ahead.

The desire to stop children taking time off school sick, and to help them avoid worrying about the pandemic and learning to get on with their peer group were together judged to tip the balance in favour of vaccination.

Sources close to Whitty stressed that he was still holding discussions and was yet to finalise his recommendations, but the backing of his top advisers means that vaccination of children is in effect agreed.

Worth reading in full.

Teenage Boys Six Times More Likely to Suffer Heart Problems from Vaccine Than to Be Hospitalised from Covid, According to New Study

As the Government tries to push on with the vaccination of healthy children against Covid, despite warnings from the Joint Committee on Vaccination and Immunisation (JCVI), a major new U.S. study has found that teenage boys are six times more likely to suffer from heart problems due to the vaccine than to be hospitalised from Covid. This should force ministers to think twice. The Telegraph has the story.

Children who face the highest risk of a “cardiac adverse event” are boys aged between 12 and 15 following two doses of a vaccine, according to new research from the U.S. 

The findings come as Professor Chris Whitty, England’s Chief Medical Officer, prepares to advise ministers on whether there is a wider benefit to society from vaccinating children.

Last week, the JCVI delivered its long-awaited verdict, saying the “margin of benefit” of jabbing 12 to 15 year-olds was “considered too small” and citing the low risk to healthy children from the virus.

However, Sajid Javid, the Health Secretary, said he wanted Prof Whitty and the Chief Medical Officers from Scotland, Wales and Northern Ireland to “consider the vaccination of 12 to 15 year-olds from a broader perspective”. …

Research published on Thursday will prompt fresh concerns about whether the risk of the vaccine outweighs the benefits for otherwise healthy children.

A team led by Dr. Tracy Hoeg at the University of California investigated the rate of cardiac myocarditis – heart inflammation – and chest pain in children aged 12-17 following their second dose of the vaccine.

They then compared this with the likelihood of children needing hospital treatment owing to Covid, at times of low, moderate and high rates of hospitalisation.

Researchers found that the risk of heart complications for boys aged 12-15 following the vaccine was 162.2 per million, which was the highest out of all the groups they looked at.

Evidence from studies show it is unlikely for boys to suffer either heart problems from the vaccine or be hospitalised by Covid.

The second highest rate was among boys aged 16-17 (94.0 per million) followed by girls aged 16-17 (13.4 per million) and girls aged 12-15 (13.0 per million).

Meanwhile, the risk of a healthy boy needing hospital treatment owing to Covid in the next 120 days is 26.7 per million. This means the risk they face from heart complications is 6.1 times higher than that of hospitalisation.

This is based on current rates of hospitalisations from Covid-19, which are judged to be “moderate”. During a period of low risk of hospitalisation, such as June 2021, the likelihood of heart complications rises to 22.8 times higher, and during a period of high risk, such as January 2021, the likelihood of heart complications is still 4.3 times higher.

The study, which has not yet been peer reviewed, analysed reports of adverse effects children have suffered from the vaccine between January and June of this year.

The study looked at MRNA vaccines – such as Pfizer and Moderna – which will be particularly relevant for Britain because youngsters will not be given the AstraZeneca jab because of the increased risk of dangerous blood clots.

Worth reading in full.

Stop Press: Ross Clark has written about the risk mRNA vaccines pose to young boys in the Spectator.

Stop Press 2: Dame Sarah Gilbert, the driving force behind the AstraZeneca vaccine, has told the Telegraph there’s no need to vaccinate healthy 12-15 year-olds and we’d be better off exporting any spare vaccines we have to low income countries.